In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new therapeutic goods advertising measures within two years from the commencement of the changes to the Therapeutic Goods Act 1989 to support these measures.
The independent review of the reforms to the therapeutic goods advertising framework, conducted by Ms Rosemary Sinclair AM during the first half of 2020, has been completed and the report now published.
The review assessed the impact of the advertising reforms arising from the 2015 Expert Panel Review of Medicines and Medical Devices Regulation.
The Government has accepted all 22 recommendations in the report.
The agreed actions, once implemented, will deliver improvements and refinements to the therapeutic goods advertising framework, including:
- the development, in consultation with stakeholders, of annual advertising compliance priorities, for outcomes and consumer-focused approach to advertising compliance.
- implementation of more strategic advertising complaints handling that uses complaints as a source of intelligence, to be used for individual case selection and in determining compliance priorities.
- the development and publication of new key performance indicators focused on priorities and outcomes rather than processes and deadlines.
- the publication of case studies based on case experience to assist advertisers and consumers to understand the legal requirements for advertising therapeutic goods, in conjunction with the ongoing publication of policy clarification as needed.
- improved flexibility, so as to be adaptable to emerging issues, and improved transparency through media and publications, as modeled on our response to compliance during the COVID-19 pandemic.
- implementation of an education and stakeholder engagement strategy, aligned with compliance priorities and supported by education priorities, which focuses on consumer and industry benefit.
- enhanced collaboration and engagement with other Australian regulators.
- enhancing the operation of the Therapeutic Goods Advertising Consultative Committee.
More information could be obtained here:-
https://www.tga.gov.au/independent-review-reforms-therapeutic-goods-advertising-framework-complete